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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapySelf-organizer, meticulous hands-on habits, keen attention to detail.
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Assist in the preparation and review of bioanalytical data and reports suitable for regulatory submission. Background in molecular biology techniques such as cloning, site-directed mutagenesis, DNA and RNA isolation and purification, sequencing, RT-PCR, and qPCR.
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Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
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Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
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Familiarity with FDA regulatory process. PharmD or PhD in the STEM disciplines: bioinformatics, Public Health, Pharmacology, Toxicology, Biology, Biomedical Engineer, biology, biostatistics, epidemiology, health informatics, or pharmaceutical science.
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Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO's/CDMO's. The candidate will work with Chief Technology Officer to lead authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met.
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Collaborate closely with and provide direction to cross-functional partners (e.g. Customer & Disease Strategy, Insights & Analytics, Market Access, Medical, Sales, Training, Corporate Affairs) for the development and implementation of both strategic and operational plans.
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Experience in the financial industry demonstrating knowledge of regulatory reporting and analytical skills is preferred. FINRA is a registered trademark of the Financial Industry Regulatory Authority, Inc.
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Experienced with protocol navigation, regulatory affairs, and IRB submissions. Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB.
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In today's fast-paced and complex global economy, FINRA is a trusted advocate for investors, dedicated to keeping the markets fair and proactively addressing emerging regulatory issues before they harm investors or the markets.
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Assists the Director in special projects and other regulatory compliance-related initiatives. We have an exciting opportunity for a Principal Analyst, MRTS Regulatory Compliance: The Principal Analyst in MRTS Regulatory Compliance is responsible for a wide range of tasks in support of various regulatory compliance functions for Market Regulation and Transparency Services (MRTS), including those related to responding to government access and data requests, coordinating former employee reviews, and administering department-wide policies and procedures.
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Write and review standard operating procedures for cell line development processes and instrumentation under the direction of the FTL. Maintain complete documentation records, including a detailed and up-to-date laboratory notebook, to support regulatory filings.
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Oversee the related expansion and optimization of global capabilities across manufacturing, quality, process development, analytical development, supply chain, and regulatory affairs. Collaborate closely with the Chief Operating Officer and their leadership team to effectively manage operations concerning the Novavax COVID vaccine, the company's proprietary MATRIX adjuvant product, and the global launch of new COVID variant vaccines, alongside innovative products like the Flu-COVID Combination vaccine (CIC.
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The Biologics Virus Clearance Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
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Bachelor's degree or foreign equivalent in Regulatory Affairs, Life Sciences, Computer Science, Information Technology, or related field. Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the Office of Regulatory Support (ORS), Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS.
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regulatory affairs jobs Title: sr director Company: Biogen in Rockville, MD
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